Is IQ necessary for laser marking validation?

zeypzeyn

Starting to get Involved
#1
Trying to validate laser marking process for class Im surgical instruments. Is the "installation qualification" needed for the report? I couldn't decide the installation of the laser marking machine is going to be the part of the validation report. Or just OQ and PQ ?

Note: This is my first validation study :)
 
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yodon

Staff member
Super Moderator
#2
First off, IQ/OQ/PQ are just pretty typical means to support validation. There's nothing specifically requiring those particular activities. They do represent a well-structured approach to the process, IMO.

Stepping back, consider what the purpose of validation is: to ensure your process can consistently / repeatedly produce compliant product as long as you are making that product.

Are there factors in the setup that could impact the ability to make product to spec? Answer that and you probably have your answer on whether IQ is needed. (Well, that and whatever your internal procedures say - your internal procedures may well say that IQ is required, regardless.) Power input, stability, safety, etc. are all typical considerations for IQ.
 

zeypzeyn

Starting to get Involved
#3
First off, IQ/OQ/PQ are just pretty typical means to support validation. There's nothing specifically requiring those particular activities. They do represent a well-structured approach to the process, IMO.

Stepping back, consider what the purpose of validation is: to ensure your process can consistently / repeatedly produce compliant product as long as you are making that product.

Are there factors in the setup that could impact the ability to make product to spec? Answer that and you probably have your answer on whether IQ is needed. (Well, that and whatever your internal procedures say - your internal procedures may well say that IQ is required, regardless.) Power input, stability, safety, etc. are all typical considerations for IQ.
Thank you very much for the informative response. From this perspective, the installation of the laser marking machine seems to be irrelavant for the correct position of marking on device.
 

yodon

Staff member
Super Moderator
#4
Think broadly. Are all the safety mechanisms properly installed (e-stop, door interlocks, etc.)? I would presume the system has embedded software - do you have the right version? Are there known bugs in the software that might impact operations? Are physical / logical controls in place to ensure only authorized employees can safety operate the system? I presume there's data that drives the specific markings - is that set up to only allow authorized employees to create / update such data? Do you have all the required documentation? Are PM procedures established?
 
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